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SAMJ: South African Medical Journal

versão On-line ISSN 2078-5135
versão impressa ISSN 0256-9574

SAMJ, S. Afr. med. j. vol.105 no.11 Pretoria Nov. 2015

 

5. Damrongplasit K, Melnick G. Funding, coverage, and access under Thailand's universal health insurance program: An update after ten years. Appl Health Econ Health Policy 2015;13(2):157-166. [http://di.doi.org/10.1007/s40258-014-0148-z]        [ Links ]

6. Ha BTT, Frizen S, Thi LM, Duong DTT, Duc DM. Policy processes underpinning universal health insurance in Vietnam. Glob Health Action 2014;7:24928. [http://dx.doi.org/10.3402/gha.v7.24928]        [ Links ]

7. Glassman A, Chalkidou K. Priority-setting in Health: Building Institutions for Smarter Public Spending. Washington, DC: Center for Global Development's Priority-setting Institutions for Global Health Working Group, 2012.         [ Links ]

8. Giedion U, Bitran R, Tristao I, eds. Health Benefit Plans in Latin America: A Regional Comparison. Washington, DC: Inter-American Development Bank Social Protection and Health Division, 2014.         [ Links ]

9. Pichon-Riviere A, Augustovski F, Garcia Marti S, Sullivan SD, Drummond M. Transferability of health technology assessment reports in Latin America: An exploratory survey of researchers and decision makers. Int J Technol Assess Health Care 2012;28(2):180-186. [http://dx.doi.org/10.1017/S0266462312000074]        [ Links ]

10. Goeree R, He J, O'Reilly D, et al. Transferability of health technology assessments and economic evaluations: A systematic review of approaches for assessment and application. Clinicoecon Outcomes Res 2011;3:89-104. [http://dx.doi.org/10.2147/CEOR.S14404]        [ Links ]

11. Health Information and Quality Authority. Guidelines for Stakeholder Engagement in Health Technology Assessment in Ireland. Dublin: Health Information and Quality Authority, 2014.         [ Links ]

12. National Institute for Health and Clinical Excellence. The Guidelines Manual. November 2012. http://www.nice.org.uk/article/pmg6/chapter/11-the-consultation-process-and-dealing-with-stakeholder-comments (accessed 10 July 2015).         [ Links ]

13. South African National Department of Health. National Health Act 61 of 2003. 2003. http://www.gov.za/sites/www.gov.za/files/a61-03.pdf (accessed 7 August 2015).         [ Links ]

14. Hailey D. Development of the International Network of Agencies for Health Technology Assessment. Int J Technol Assess Health Care 2009;25(Suppl 1:)24-27. [http://dx.doi.org/10.1017/S0266462309090370]        [ Links ]

15. Teerawattananon Y, Tritasavit N, Suchonwanich N, Kingkaew P. The use of economic evaluation for guiding the pharmaceutical reimbursement list in Thailand. Z Evid Fortbild Qual Gesundhwes 2014;108(7):397-404. [http://dx.doi.org/10.1016/j.zefq.2014.06.017]        [ Links ]

16. Chiu W-T, Pwu R-F, Gau C-S. Affordable health technology assessment in Taiwan: A model for middle-income countries. J Formos Med Assoc 2015;114(6):481-483. [http://dx.doi.org/10.1016/j.jfma.2015.01.016]        [ Links ]

17. Teerawattananon Y, Tantivess S, Yothasamut J, Kingkaew P, Chaisiri K. Historical development of health technology assessment in Thailand. Int J Technol Assess Health Care 2009;25(Suppl. 1):1-12. [http://dx.doi.org/10.1017/S0266462309090709]        [ Links ]

18. Augustovski F, Alcaraz A, Caporale J, Garcia Marti S, Pichon Riviere A. Institutionalizing health technology assessment for priority setting and health policy in Latin America: From regional endeavors to national experiences. Expert Rev Pharmacoecon Outcomes Res 2014;15(1):9-12. [http://dx.doi.org/10.1586/14737167.2014.963560]        [ Links ]

19. Facey K. International HTA Glossary: English Version: International Network of Agencies for Health Technology Assessment (INAHTA). 2006. http://htaglossary.net/HomePage (accessed 1 June 2015).         [ Links ]

20. National Department of Health. Tertiary and Quaternary Level Essential Medicines Recommendations. Pretoria: NDoH, 2015.         [ Links ]

21. Council for Medical Schemes. Methodology to Assess the Cost Impact of PMB Benefit Definitions. Pretoria: CMS, 2012.         [ Links ]

22. Chola L, Pillay Y, Barron P, Tugendhaft A, Kerber K, Hofman K. Cost and impact of scaling up interventions to save lives of mothers and children: Taking South Africa closer to MDGs 4 and 5. Glob Health Action 2015;8:27265. [http://dx.doi.org/10.3402/gha.v8.27265]        [ Links ]

23. Chola L, McGee S, Tugendhaft A, Buchmann E, Hofman K. Scaling up family planning to reduce maternal and child mortality: The potential costs and benefits of modern contraceptive use in South Africa. PloS One 2015;10(6):e0130077. [http://dx.doi.org/10.1371/journalpone.0130077]        [ Links ]

24. Volmink HC, Bertram MY, Jina R, Wade AN, Hofman KJ. Applying a private sector capitation model to the management of type 2 diabetes in the South African public sector: A cost-effectiveness analysis. BMC Health Serv Res 2014;14:444. [http://dx.doi.org/10.1186/1472-6963-14-444]        [ Links ]

 

 

Corresponding author: K J Hofman (karen.hofman@wits.ac.za)

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EDITORIAL

 

Reforming South Africa's procedures for granting patents to improve medicine access

 

 

Led by the Department of Trade and Industry (DTI), South Africa (SA) is undergoing a process of reviewing and amending national laws governing the protection of intellectual property (IP). This process has the potential to remedy significant shortcomings in the current legislation that allow for the granting of an excessive number of patents, and evergreening of monopoly periods, at the expense of medicine access.

As a member of the World Trade Organization, SA is required to uphold minimum standards of IP protection as defined by the international Agreement on Trade Related Aspects of Intellectual Property Rights (the 'TRIPS' agreement). The TRIPS agreement requires SA to grant 20 years of patent protection on products and processes that meet SA's patentability criteria. These criteria are the standards of novelty, innovativeness and industrial applicability required to receive a patent.[1]

A key shortcoming of SA's current IP system is that the majority of patents granted fail to meet the country's patentability criteria.[2] Patents that do not meet the country's patentability criteria are granted as a result of the depository system used for granting patents in the country without examination of their merits.[2-4]

In observing their TRIPS obligations, countries may use depository or examination systems for granting patents.[3-5] In countries with depository systems, patent applicants are simply required to file the correct forms and pay the requisite fees in order to receive a patent. In other words, nobody checks patent applications to ensure that patentability criteria are met prior to the granting of patents. Conversely, under examination systems, the merits of a patent application are reviewed and applicants must demonstrate that patentability criteria have been met in order to receive monopoly protection.[3,4]

Given the lack of examination in SA, many patents are granted in this country that are rejected by countries and regions - including Brazil, the USA and the European Union (EU) - that have examination systems in place.[4,6]

A comparative analysis showed that SA granted 66% more pharmaceutical patents than the USA and the EU on identical patent applications filed between 2000 and 2002.[6] Another study demonstrated that SA granted 2 442 pharmaceutical patents in 2008 alone, while in comparison, Brazil granted only 278 in the 6 years between 2003 and 2008.[4]

The ease with which pharmaceutical patents are granted in SA permits pharmaceutical companies to gain multiple, successive patents on individual medicines, extending their periods of monopoly protection beyond the 20 years required by the TRIPS agreement. This practice is commonly known as 'evergreening'.

The challenge of evergreening in SA was highlighted in recent litigation over patents held on the popular birth control pill containing drospirenone and ethinyl oestradiol, sold by pharmaceutical company Bayer as Yasmin. The initial 20-year period of patent protection on this medicine ended in 2010 in SA. However, secondary, evergreening patents prevented generic versions from being brought to the market at a 30% price reduction when the initial patent expired. The Supreme Court of Appeal in Bloemfontein upheld Bayer's secondary patent in 2014, which means that generic use may continue to be blocked until 2024. Generic versions are already available in the USA and countries in Europe following rejection of Bayer's secondary patents in these countries.[7]

The hepatitis B medicine entecavir, marketed by Bristol-Myers Squibb in SA as Baraclude, further demonstrates the challenge of evergreening. The initial patent on this medicine expired in 2011, but secondary patents could prevent use of generic equivalents until 2026. Given the high local cost of Baraclude - between ZAR4 700 and ZAR5 500 per month for a hepatitis B patient - entecavir is not currently provided in the public sector. Yet generic equivalents are available outside SA at one-tenth of the price charged by the patent holder.[7]

Similarly, generic versions of aripiprazole (marketed in SA as Abilify), used to treat depression and bipolar disorder, are now available in the USA, yet secondary patents may block availability of generics in SA until 2033. SA consumers pay up to 35 times more for aripiprazole than those in India, where generic competition exists.'71

Excessive patenting and evergreening of monopoly periods prevents South Africans from accessing more affordable, generic versions of many medicines, despite their widespread use and availability in other parts of the world. To address this challenge, SA must amend its laws and procedures for examining applications and granting patents.

Encouragingly, the DTI is currently undertaking a process of reviewing and amending SA's IP legislation. During 2013, the DTI released a Draft National Policy on Intellectual Property for public comment that contained commitments to pro-public health reform. According to the DTI, the finalised policy will be adopted this year, after which bills to amend IP legislation will be brought before Parliament.

The Fix the Patent Laws coalition has called on the DTI to urgently release a finalised policy recommending key reforms to curb evergreening and improve medicine access. The Fix the Patent Laws coalition comprises 15 health organisations in SA that represent patients seeking treatment and care in the realms of HIV, tuberculosis, sexual and reproductive health, cancer, mental health conditions, diabetes and other non-communicable diseases.

The reforms recommended by the Fix the Patent Laws coalition include, among others, setting stricter patent standards and requiring examination of pharmaceutical patent applications.

Under the TRIPS agreement, SA has the flexibility to set stricter patentability criteria that explicitly restrict patent evergreening. TRIPS-compliant countries - India, Argentina and the Philippines -have adopted legislation or patent examination guidelines that limit or prevent patenting of new formulations (new dosages, combinations or forms (i.e. isomers, salts or polymorphs) of existing medicines) and new uses (new clinical uses of medicines other than those for which they are already registered or sold), except in very limited circumstances. Brazil is currently considering legislation to restrict these types of patents. In amending its patent legislation, SA should adopt similarly strict criteria to ensure that only truly innovative compounds and processes are granted monopoly protection.

In addition to setting stricter patentability criteria, SA must amend its system for granting patents to ensure that only patents meeting patentability criteria are granted. To do this, the country must replace its depository system with an examination system. In order to implement patent examination, SA will have to overcome capacity challenges.

The feasibility of an examination system in SA is currently the subject of rigorous debate.[8] Discussions have centred largely on the human resource requirements for implementing examination, and whether SA can attract and hire sufficient numbers of qualified examiners. Patent examiners often have advanced degrees in their fields, and must have sufficient technical knowledge to judge the merits of a patent application. During 2013, the Indian Patents Office reported that 337 patent examiners were employed in the country.[5]

Attracting and hiring sufficient patent examiners will be a hurdle to implementing examination in SA. However, there are different approaches and models that could be pursued.[1,3]

 

A partial or phased approach

A partial or phased approach would initially focus on implementing examination for a few key sectors. This would reduce the number of examiners that the country would initially need to hire and train, allowing for capacity building over time. A partial or phased-in approach should initially focus on implementing examination for sectors that impact on government's ability to achieve its constitutional obligations - such as realising the right to health.[1,3]

 

A collaborative approach

A collaborative approach would allow SA to share the workload of examination with the patent offices of other countries or regions. If SA were to draw on decisions from other patent offices, many applications could be rejected automatically. However, in pursuing such an approach, careful consideration would have to be paid as to which patent offices ought to be selected for collaboration, taking into account that country and regional IP priorities and patentability criteria frequently differ. A rational approach would be for SA to collaborate with patents offices with comparable patentability criteria and adequate capacity for examination, in countries with similar socioeconomic backgrounds.[3]

 

An opposition approach

Patent opposition procedures are commonly used in many TRIPS-compliant developed, and developing, country patent offices with examination systems in place.

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